Customers and certificates

SUNRISE SA

Business Sector:
Medical devices incorporating / utilising / controlled by software, Other active non-implantable devices for monitoring and/or diagnosis, Software development (including software validation)
Reference No.:
538467
Certified according to :

ISO 13485:2016 (MDSAP Audit Model Edition 2)

This certification belongs to the parent company 538467 SUNRISE SA

Scope:

Design, development, manufacture, distribution of medical devices software and programmable electrical systems for aid in the diagnosis and therapy of sleep related disorders. - USA (a,b,c,d) REPs FEI No.: F007776

Certified according to :
Scope:

Design, development, manufacture, distribution of medical devices software and programmable electrical systems for aid in the diagnosis and therapy of sleep related disorders. - USA (a,b,c,d) REPs FEI No.: F007776

Certified according to :

Medical Devices VO (EU) 2017/745

Download certificate : 23.02.2026 englisch

Scope:

MDA 0315 – Standalone Software - Sunrise sleep disorder diagnostic aid

Certified according to :
Scope:

Design, development, manufacture and distribution of medical device software and programmable electrical medical systems for aid in the diagnosis and therapy of sleep related disorders.